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Objective: To quantify clinical and cost long-term outcomes in cardiovascular stable post-myocardial-infarction patients., Research Design and Methods: Subjects with a history of myocardial infarction (MI) who were 50-64 years old and MI- and stroke-free for ≥12 months (index date) were identified in a large US claims database. Individuals were followed for up to 5 years (mean: 2.0 years) after their index date., Main Outcome Measures: Rates of MI, stroke, all-cause death, and a composite of these were analyzed via Cox regression models, adjusted for covariates. Results are reported for the overall population and the subgroups of those with type 2 diabetes, additional prior MI, and non-end-stage renal disease. As a secondary endpoint healthcare costs were evaluated at baseline and during each year of follow-up. Results Over the follow-up period, which averaged 2 years, 7.6% of all 13,492 subjects (10.5% vs. 5.4% with and without the selected risk factors, respectively) experienced at least one of the outcome events. The cumulative incidence rates over the entire follow-up period for the primary composite outcome were 20.8% and 12.2% for those with and without the selected atherothrombotic risk factors, respectively. The cardiovascular-related per-person-per-year healthcare costs during follow-up were higher in those with ≥1 additional risk factor compared to those without: $15,247 versus $7521. Costs were elevated over baseline costs throughout follow-up., Limitations: Administrative claims data lack clinical detail. Generalizability of results is limited to the US commercially insured population of a similar age to that included in this study., Conclusions: High risk MI survivors who have been event free for ≥1 year remained at substantial risk of CV events and had increased healthcare costs for up to 5 years post-MI. These long-term risks have not been previously demonstrated in a working-age US population and suggest an unmet need for continuing secondary prevention long-term post-MI.

Background: Few trials have compared different approaches to cardiovascular disease prevention among Pacific Asian (PA) populations. The Cluster Randomized Usual Care versus Caduet Investigation Assessing Long-term-risk (CRUCIAL) trial demonstrated that a proactive multifactorial intervention (PMI) approach (based on single-pill amlodipine/atorvastatin) resulted in a greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) among hypertensive patients with additional risk factors. One-third of CRUCIAL patients resided in the PA region. The aim of this subanalysis was to compare two approaches to cardiovascular risk factor management (PMI versus UC) among patients residing in PA and non-PA regions., Methods: This subanalysis of the CRUCIAL trial compared treatment-related changes in calculated CHD risk among patients residing in PA and non-PA regions. Sensitivity analyses were conducted among men and women and those with and without diabetes., Results: Overall, 448 patients (31.6%) resided in the PA region and 969 patients (68.4%) resided in non-PA regions. The PMI approach was more effective in reducing calculated CHD risk versus UC in both PA (-37.1% versus -3.5%; P<0.001) and non-PA regions (-31.1% versus -4.2%; P<0.001); region interaction P=0.131. PA patients had slightly greater reductions in total cholesterol compared with non-PA patients. PA patients without diabetes had slightly greater reductions in CHD risk compared with non-PA patients. Treatment effects were similar in men and women and those with diabetes., Conclusion: The PMI approach was more effective in reducing calculated Framingham 10-year CHD risk compared with UC among men and women with and without diabetes residing in the PA and non-PA region.

Despite race, ethnic, and regional differences in cardiovascular disease risk, many worldwide hypertension management guidelines recommend the use of the Framingham coronary heart disease (CHD) risk equation to guide treatment decisions. This subanalysis of the recently published CRUCIAL trial compared the treatment-related reductions in calculated CHD and stroke risk among Pacific Asian (PA) patients using a variety of region-specific risk assessment models. As a result, greater reductions in systolic and diastolic blood pressure, low-density lipoprotein cholesterol, and triglycerides were observed in the proactive multifactorial intervention (PMI) arm compared with the usual care arm at Week 52 for PA patients. The relative percentage change in 10-yr CHD risk between baseline and Week 52 in the PMI versus usual care arms was greatest using the NIPPON DATA80 fatal CHD model (LS [least square] mean difference -42.6%), and similar in the SCORE fatal CHD and Framingham total CHD models (LS mean difference -29.4% and -30.8%, respectively). The single-pill based PMI approach is consistently effective in reducing cardiovascular disease risk, evaluated using a variety of risk assessment models. (ClinicalTrials.gov registration number: NCT00407537).

Objective: To investigate whether a proactive multifactorial risk factor intervention strategy using single-pill amlodipine/atorvastatin (5/10, 10/10 mg) in addition to other antihypertensive and lipid-lowering therapy, as required, resulted in greater reduction in calculated Framingham 10-year coronary heart disease (CHD) risk compared with usual care (UC) after 52-weeks treatment., Research Design and Methods: Prospective, multinational, open-label, cluster randomized trial, with the investigator as the unit of randomization. Eligible hypertensive patients were 35-79 years of age, with ≥3 additional cardiovascular risk factors, but no history of CHD and baseline total cholesterol (TC) ≤6.5 mmol/l., Clinical Trial Registration: www.ClinicalTrials.gov ; trial identifier NCT00407537., Main Outcome Measure: The primary endpoint was calculated Framingham 10-year CHD risk at 52 weeks., Results: Of the 140 randomized sites, 136 sites contributed 1461 patients. Mean baseline age and low-density lipoprotein cholesterol (LDL-C) were comparable between treatment arms. Mean baseline BP (150.3/89.7 vs. 144.3/86.5 mmHg) and Framingham CHD risk (20.0 vs. 18.1%) were higher in the proactive intervention versus the UC arm (p < 0.002 for both). At week 52, mean CHD risk was 12.5% in the proactive intervention arm and 16.3% in the UC arm (p < 0.001). The difference, observed at weeks 16 and 52, was primarily driven by significant differences in systolic BP and in TC between the two arms. Overall, adverse events (AEs) were reported in 48.8% and 44.0% of patients in the proactive intervention and the UC arm, respectively. Although there were differences in the incidence of AEs between the treatment arms, the AE profile in the proactive intervention arm was consistent with previous safety experience for this medication., Conclusions: A proactive multifactorial risk factor intervention strategy that simultaneously treated both BP and cholesterol regardless of individual risk factors per se, is more effective in reducing calculated Framingham 10-year CHD risk than UC in patients with hypertension and additional risk factors.

The CRUCIAL trial was designed to compare the relative reduction in calculated Framingham coronary heart disease risk when a multiple risk factor intervention strategy, based on single-pill amlodipine besylate/atorvastatin calcium, was compared with a usual-care strategy. Eligible patients had treated or untreated hypertension, >or=3 additional cardiovascular risk factors, and baseline total cholesterol

Introduction: The objectives of this study were, first, to describe the status of implementation of clinical guidelines for prevention of ischaemic heart disease in subjects with arterial hypertension, dyslipidemia and type 2 diabetes, but without known cardiovascular disease, and, second, to describe the changes in treatment following journal audit and education of GPs., Material and Methods: 230 general practitioners (GPs) were invited to include 20 consecutive at-risk patients. One year after the first data collection of 3,555 patients by 182 GPs, a new set of 3,023 patients was collected by 170 GPs from a new patient population. In the period between the two surveys, the GPs were educated through workshops and an international meeting focusing on cardiovascular risk factor treatment., Results: The quality of the care being delivered was suboptimal. Approximately 15-40% of the patients had obtained the treatment goals for hypertension, dyslipidemia and type 2 diabetes. Some improvement was demonstrated following education and journal audit, but a gap still exists between the recommended treatment and the treatment patients actually receive., Conclusion: There is a need for improvement in the implementation of clinical guidelines focusing on diabetes and cardiovascular disease.